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Graft Versus Host Disease

Depletion of T Cells From Allogeneic Stem Cell Grafts for the Prevention of GVHD (FHCRC-2222)
A Multi-center Phase II Study of Selective Depletion of CD45RA+ T cells from Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD
Status Conditions Phase Study ID
Recruiting Acute Lymphoid Leukemia (ALL);
Acute Myeloid Leukemia (AML)
Hematologic Malignancies
Myelodysplastic Syndromes (MDS) Myeloproliferative Syndromes (MPD)
Phase II FHCRC-2222
NCT00914940
Summary

The purpose of this study is to determine the effects, good or bad, of an experimental type of transplant in people with acute leukemia or advanced myelodysplastic syndromes. This study is being done to see whether or not this type of transplant protects study participants against graft-vs-host disease (GVHD). (GVHD is a complication that can happen after a transplant.)

The type of transplant used in this study is called a selective T-cell depleted transplant. Certain cells (CD45RA+ naive T-cells) will be removed from the donated stem cells in the laboratory after the cells are collected from the donor but before they are given to the study participant. The naïve T cells are thought to cause GVHD.

Participants will receive outpatient treatment at the Seattle Cancer Care Alliance (SCCA) and will be admitted to the University of Washington Medical Center (UWMC) or Seattle Children?s for those parts of their care requiring hospitalization.

All study procedures will be completed by about one year after transplant. After that point we will be monitoring study participants as part of the long-term follow-up program for post-transplant complications.


Investigator
Marie Bleakley, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Diagnosed with acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) or advanced myleodysplastic syndrome (MDS)
  • Age 14-55
  • Eligible for allogeneic hematopoietic stem cell transplantation (HSCT)
  • Appropriately matched, sibling donor is available

 

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)
  • Pregnant or breast-feeding
  • Undergoing second hematopoietic stem cell transplantation (HSCT)
  • Central nervous system (CNS) involvement that does not respond to intrathecal chemotherapy and/or standard cranial-spinal radiation
  • HIV+
  • Uncontrolled infections
  • Organ dysfunction
  • Known hypersensitivity to tacrolimus

 

Other exclusion criteria may apply.

Last Updated
May 26, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.